Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04021381
Other study ID # P170933J
Secondary ID 2018-A03500-55
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 25, 2020
Est. completion date June 2022

Study information

Verified date October 2021
Source Assistance Publique - Hôpitaux de Paris
Contact Nathalie TABIBZADEH, MD
Phone + 33 1 56 01 83 29
Email nathalie.tabibzadeh@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The prevalence of urolithiasis is around 10 % in the French population. It is thus a major public health issue. When the stone is not spontaneously removed, interventions such as extracorporeal lithotripsy or flexible ureteroscopy (F-URS) are performed. F-URS is usually preferred in renal stones > 7 mm in comparison with lithotripsy, with better results. Efficacy of ureteroscopy is based on the "stone-free rate" (SFR) at 3 months. A SFR index is assessed according to the existence of residual fragments and their size. SFR score 1 (fragment ≤ 1mm) has been poorly studied, and is supposed to occur in 60% of cases. These residual fragments account for the high frequency of recurrence, probably favored by crystals aggregation and growth of these fragments under supersaturated urines. Indeed, calcium stones risk factors are urine supersaturation and crystal growth inhibitors deficiency. Citrate is the major crystal growth inhibitor in human urine. A hypocitraturia is reported in half of the lithiasic population. Consequently, citrate salts appear as an interesting therapeutic option, in order to slow crystal growth but also to chelate calcium, and consequently to solubilize stones in situ. However, to date, there is no available controlled study after surgical intervention such as flexible ureteroscopy. The aim of the investigator's study is to evaluate the efficacy of a 3-month potassium and magnesium citrate treatment following ureteroscopy on the elimination of residual fragments (SFR score 1).


Description:

The screening visit takes place 3 months to 3 days before the baseline visit. Patient will be informed of the study protocol by the surgeon who will perform the flexible ureteroscopy. As usual in clinical practice, a CT scan will be routinely performed. CT-scan interpretation will be centralized and performed blindly. At the ureteroscopy day (baseline visit: Some sites, according to their usual practice, may admit their patients to hospital the day before the surgery (D-1)), inclusion and exclusion criteria will be checked by the surgeon. A second information on the study protocol will be given and the protocol consent will be signed. The day of hospital admission, blood and urine will be collected by a nurse in order to define stone risk factors and other comorbidities after informed consent of the patients. Then patients will undergo ureteroscopy. Stone fragments will be sent for analysis to the stone centre Laboratory (Tenon Hospital, Paris) with images of the stones during surgery (morphoconstitutional analysis). Patients will be randomized for treatment within 7 days following F-URS, and after verification of randomization criteria. If the randomisation criteria are not completed, the patient will end its participation to the study. Else, the patient is randomized and treatment for 3 months (placebo or citrate salts, blinded) will be delivered by the investigational site and administration will begin the day following surgery, thus discharge. A 33 cl glass will be provided for the administration of the treatment. Furthermore 24-hour urine collection will be explained and patients will be given the vessel in order to collect urine at M3 visit. The end of study visit will take place at 3 months +/- 10 days after ureteroscopy visit. Medical check-up by the urologist in charge, including a CT-scan and blood and urine biological tests under randomized treatment. Randomized treatment will be stopped the day of this M3 visit. Adverse events (including drug tolerance, urinary symptoms) and date of stent removal if any will be collected. Compliance will be assessed, using a log book.


Recruitment information / eligibility

Status Recruiting
Enrollment 262
Est. completion date June 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years old - Efficient contraceptive method in women of childbearing age - At least one renal urolithiasis 10 = size = 20 mm - No recent ureterorenoscopy (< 6 months) - Planned flexible ureterorenoscopy procedure with holmium-laser dusting - CT-scan performed within 3 months before surgery - Affiliation to a social security regime - Informed consent Exclusion Criteria: - Stone density < 700 UH on pre-operative CT-scan - History of infectious renal stones or monogenic lithiasic disease (cystinuria, primary hyperoxaluria) - Obstructive urinary tract malformation Cacchi-Ricci disease, Horseshoe kidney - Chronic renal failure (eGFR<30 ml/min/1.73m²) - Ongoing renal colic (within 7 days) - Untreated urinary tract infection (within 7 days) - Contraindications to ureterorenoscopy: coagulation disorders, high anesthetic risk - Contraindications to potassium and magnesium citrate: known hyperkalemia, known hypermagnesemia, uncontrolled diabetes, acute dehydration - Pregnant or breastfeeding women - Patient deprived of liberty or under legal protection measure (tutorship or curatorship); - Participation in another therapeutic trial

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Potassium and magnesium citrate
Patients are treated with potassium and magnesium citrate 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.
Placebo
Patient are treated with placebo 5.2 grams daily during 3 months, following flexible ureterorenoscopy for inferior calyx urolithiasis.

Locations

Country Name City State
France Department : Exploration fonctionnelles rénales, Centre de la lithiase Hôpital TENON Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stone-free result Percentage of stone-free patients (SFR score 0 and 1) between the 2 groups at 3 months after ureteroscopy assessed by non-injected, low irradiation, thin slice CT-scan. 3 months
Secondary SFR score 2, 3 and 4 Percentage of SFR score 2, 3 and 4 in the 2 groups at 3 months assessed by non-injected, low irradiation, thin slice CT-scan 3 months
Secondary Urine supersaturation index Urine supersaturation index calculation based on the combination of urine pH, calciuria, phosphaturia, uricosuria, oxaluria) at 3 months in the two groups 3 months
Secondary To evaluate the Safety of potassium and magnesium citrate: Percentage of patients with at least one adverse event throughout the study Percentage of patients with at least one adverse event throughout the study and collected at 3 months: epigastralgia, nausea, vomiting, bloating, constipation, diarrhea and urinary tract infection.
Mean USSQ (ureteral stone symptom questionnaire) score in each group.
3 months
Secondary To evaluate the compliance of potassium and magnesium citrate as assessed by citraturia 24-hour and fasting citraturia (mmol/L) at 3 months. 3 months
Secondary To evaluate the compliance of potassium and magnesium citrate as assessed by urinary pH 24-hour and fasting pH at 3 months. 3 months
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Completed NCT02266381 - A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy N/A
Terminated NCT01431378 - Pilot Study of Model Based Iterative Reconstruction Using 64-Slice N/A
Completed NCT01451931 - Study of Tomography of Nephrolithiasis Evaluation Phase 4
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Completed NCT02895711 - Radiation Dose of Pediatric Patients During Ureteroscopy
Completed NCT05340075 - Staged Bilateral Percutaneous Nephrolithotomy
Recruiting NCT03919227 - Measurement of Resistance During UAS Insertion Procedure in RIRS N/A
Recruiting NCT03717285 - Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS N/A
Completed NCT05340088 - Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Completed NCT05032287 - Medical Expulsive Therapy Post-SWL For Renal Stones N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Terminated NCT01736358 - The Use of Intranasal Ketoralac for Pain Management (Sprix) Phase 4
Completed NCT01792765 - Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach N/A
Completed NCT06211842 - Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Not yet recruiting NCT04606758 - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease N/A
Terminated NCT01873690 - Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI) Phase 3